Pharmaceutical sponsor
Miltenyi Biomedicine GmbH Clinical Trials
Studies where Miltenyi Biomedicine GmbH is the lead sponsor: its pipeline by phase, what is enrolling now and where. Studies it supports as a collaborator are in the search.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 14Melanoma Stage III, B-cell Non Hodgkin Lymphoma
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.
- Conditions
- Melanoma Stage III, B-cell Non Hodgkin Lymphoma, Pediatric ALL, Childhood Non-Hodgkin Lymphoma
- Trial name
- LONGSAFE (NCT06508775)
- Testing
- MB-CART19.1, MB-CART20.1, MB-CART2019.1
- Where
- 7 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Miltenyi Biomedicine GmbH
Hematological Malignancies
M-2018-334 in Hematological Malignancies
This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.
- Trial name
- HAPLO2022 (NCT06225050)
- Testing
- CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Miltenyi Biomedicine GmbH
Non Hodgkin Lymphoma, Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
- Conditions
- Non Hodgkin Lymphoma, Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma, High Grade B-cell Lymphoma
- Trial name
- NCT06116110
- Testing
- Long-term Follow-Up
- Where
- 11 sites in United States
- Volunteers
- 150 people
- Sponsor
- Miltenyi Biomedicine GmbH
ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia)
PRAISE-IR Versus CIBMTR Controls
The rationale to conduct this RWE study is to provide data to support the safety of CD34 selected grafts versus T replete PBSC transplants to address concerns about increased TRM in CD34 selected graft recipients.
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
- Trial name
- NCT07717164
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Miltenyi Biomedicine GmbH
Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma
DALY II USA/ MB-CART2019.1 for DLBCL
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory B cell lymphoma (BCL).
- Conditions
- Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma, High Grade B-cell Lymphoma (HGBCL), Primary Mediastinal B-cell Lymphoma (PMBCL)
- Trial name
- NCT04792489
- Testing
- zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide, Fludarabine
- Where
- 32 sites in United States, Canada
- Volunteers
- 315 people
- Sponsor
- Miltenyi Biomedicine GmbH
Lupus Nephritis, Systemic Lupus Erythematosus
US Zamto-cel Autoimmune Diseases
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis
- Trial name
- NCT06708845
- Testing
- zamtocabtagene autoleucel, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Miltenyi Biomedicine GmbH
Diffuse Large B-cell Lymphoma
Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients
In the current protocol version, there are two parts. Part I is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in…
- Trial name
- DALY 2-EU (NCT04844866)
- Testing
- MB-CART2019.1, Standard of Care
- Where
- 51 sites in Austria, Belgium and 12 more
- Volunteers
- 213 people
- Sponsor
- Miltenyi Biomedicine GmbH
Multiple Sclerosis, CAR T Cell Therapy
MB-CART2019.1 in Refractory Multiple Sclerosis
The goal of this trial is to assess the feasibility, safety and preliminary efficacy of MB-CART2019.1 in patients with active refractory primary and secondary progressive MS.
- Trial name
- NCT07178431
- Testing
- MB-CART2019.1
- Where
- Germany
- Volunteers
- 26 people
- Sponsor
- Miltenyi Biomedicine GmbH
Mantle Cell Lymphoma (MCL)
Frontline Risk-Adapted Optimization of Novel Targeted Immunotherapy Evaluation in High-Risk MCL
FRONTIER is a prospective, single arm, open label, multi-center, Phase II study of MB-CART2019.1 (Zamtocabtagene Autoleucel) therapy as frontline consolidation for high-risk Mantle Cell Lymphoma (MCL) participants
- Trial name
- FRONTIER (NCT07569965)
- Testing
- zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide, Fludarabine
- Volunteers
- 52 people
- Sponsor
- Miltenyi Biomedicine GmbH
B-Cell Neoplasm
Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms
This is a single-arm, multi-center, open-label Phase II study to determine the safety and efficacy of MB-CART2019.1 in pediatric and adolescent subjects (aged between 6 months and <18 years, ≥6 kg body weight [BW]) with mature…
- Trial name
- DALY PED (NCT06508931)
- Testing
- zamtocabtagene autoleucel (MB-CART2019.1)
- Where
- 5 sites in France, Germany and 2 more
- Volunteers
- 31 people
- Sponsor
- Miltenyi Biomedicine GmbH